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Dose Escalation and Cohort Expansion Study of YS-ON-001 in Patients With Advanced Solid Tumors

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ClinicalTrials.gov Identifier: NCT03131765
Recruitment Status : Recruiting
First Posted : April 27, 2017
Last Update Posted : April 27, 2017
Sponsor:
Information provided by (Responsible Party):
Yisheng Biopharma (Singapore) Pte. Ltd.

Brief Summary:
Phase 1 study evaluating the safety and tolerability of YS-ON-001 in patients with advanced solid tumors who have limited available treatment options, and exploratory evaluation of the pharmacological effect and efficacy of YS-ON-001. The study will be conducted in two parts: dose escalation and cohort expansion

Condition or disease Intervention/treatment Phase
Cancer Biological: YS-0N-001 Phase 1

Detailed Description:

This is an open-label, Phase 1 study of YS-ON-001 vaccine administered intramuscularly (IM) as a single agent to patients with advanced solid tumors. Patients are eligible if they are refractory, resistant or intolerant to prior therapies.The study will assess YS-ON-001 administered as a single agent, three times per week for 21-days with 1 week wash out period (28 days as 1 cycle) for 12 cycles in a continuous regimen. A dose escalation design will be applied in cohorts of 3-6 patients in Part I of the study.

The starting dose will be 2ml (3 times/ week). Once the recommended phase II dose (RP2D) is established, the cohort will be expanded with at least 10 additional patients to further characterize the safety and tolerability at RP2D with specific tumour types, Breast cancer and Liver Cancer

Treatment with YS-ON-001 may be continued for up to 12 cycles or until disease progression or if patient is withdrawn or unacceptable toxicity occurs. Patients who complete 12 cycles of treatment will be considered to have completed the trial. Patients who continue to benefit from treatment after 12 cycles may have the option to continue treatment upon agreement between the investigator and sponsor, and pending study drug availability.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 41 participants
Intervention Model: Single Group Assignment
Intervention Model Description: YS-ON-001 is a single agent used for this study
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase 1, Open Label, Dose Escalation and Cohort Expansion Study of YS-ON-001 in Patients With Advanced Solid Tumors
Estimated Study Start Date : April 2017
Estimated Primary Completion Date : December 2019
Estimated Study Completion Date : December 2019

Arm Intervention/treatment
Experimental: YS-ON-001

Phase 1- Dose escalation based on YS-ON-001 safety and tolerability obtained from three subjects enrolled in a cohort (first cycle of treatment), enrollment at the next dose level or additional subjects into the ongoing cohort will occur.

Phase 1b- recommended dose determined in Phase 1. Enrollment of two expansion cohorts will be restricted to the tumour types, breast cancer and liver cancer

Biological: YS-0N-001
Cancer vaccine
Other Name: Polyinosinic-polycytidylic acid/inactivated rabies virus




Primary Outcome Measures :
  1. Safety of YS-ON-001 by monitoring any adverse events (AE) and serious adverse events (SAE) [ Time Frame: through study completion, an average of 1 year ]
    To assess the safety of YS-ON-001 in patients with advanced (metastatic and/or unresectable) solid tumors based on the identification of any adverse events through study completion

  2. Tolerability of YS-ON-001 by recording AE /SAE, clinically significant changes in lab parameters and performance status (ECOG) [ Time Frame: 6 months ]
    To assess the tolerability of YS-ON-001 in patients with advanced (metastatic and/or unresectable) solid tumors for recommended phase II dose (RP2D)

  3. Dose-limiting toxicities (DLT) [ Time Frame: For 4 weeks for DLTs ]
    Number of Participants with a Dose Limiting Toxicity (DLT)


Secondary Outcome Measures :
  1. Antitumor Activity of YS-ON-001 by imaging measurement and assessing using RECIST Version 1.1 [ Time Frame: At 2 months, 4 months., 6months, 9 months and 1 year ]
    Assessment of antitumor activity of YS-ON-001 in advanced solid tumors based on the change of response rate on RECIST v1.1 at 2 months, 4 months., 6months, 9 months and 1 year

  2. Immunogenicity of YS-ON-001 evaluated by measuring serum titre level antibody against YS-ON-001 [ Time Frame: At 3 months, 6 months, 9 months and 1 year ]
    To observe immune response in patients administered with YS-ON-001



Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Life expectancy ≥ 3 months
  • Patient with histologically or cytologically proven advanced (unresectable) or metastatic solid tumor who have failed standard therapies or are intolerant to standard therapies.Part 1: Any advanced or metastatic solid tumor patient Part 2: Selected tumor types including cytological or histologically diagnosed breast cancer and liver cancer
  • Patients with adequate bone marrow function, with absolute neutrophil count (ANC) >1,500/mm3, platelet count >100,000/mm3, and hemoglobin > 10 g/mm3
  • Patients with adequate kidney function, with serum creatinine ≤1.5 X upper limit of normal (ULN)
  • Patients with adequate liver function, with aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤2.5x ULN, total bilirubin ≤1.5x ULN ; For patients with liver metastasis, AST, ALT ≤5x ULN, Total bilirubin ≤1.5x ULN
  • Patients with adequate coagulation function, with activated partial thromboplastin time (aPTT) ≤1.5x ULN
  • Female patients, if of childbearing potential, must have a negative serum pregnancy test within 72 hours prior to the date of the first dose of study medication.
  • Female patients of childbearing potential and male patients must agree to use adequate methods of contraception with their partner starting with the screening visit up to 4 weeks after the last dose of study therapy.
  • Eastern Cooperative Oncology Group (ECOG) performance status of ≤ 2.

Exclusion Criteria:

  • Known uncontrolled seizures, central nervous system disorders, or loss of cognitive ability due to mental illness
  • Pregnant or breastfeeding, or expecting to conceive children within the projected duration of the study.
  • Patient is currently receiving or has received systemic corticosteroids within 2 weeks prior to starting study drug, or who have not fully recovered from side effects of such treatment. The following use of corticosteroids are permitted: single doses, topical applications (e.g., for rash), inhaled sprays (e.g., for obstructive airway diseases), eye drops or local injections (e.g., intra-articular).
  • Known history of human immunodeficiency virus (HIV) (HIV 1/2 antibodies).
  • Known serious, uncontrolled medical conditions that in the opinion of the investigator, will render it unsafe for the patient to receive the study therapy
  • Active autoimmune disease that has required systemic treatment in the past 2 years (i.e., with use of disease-modifying agents, corticosteroids, or immunosuppressive drugs). Replacement therapy (e.g., thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency) is not considered a form of systemic treatment.
  • Patient has not recovered (i.e., to ≤ Grade 1 or to baseline) from radiation- and chemotherapy-induced adverse events (AEs) or administration of colony-stimulating factors (including granulocyte-colony stimulating factor (G-CSF), granulocyte macrophage colony-stimulating factor (GM-CSF) or recombinant erythropoietin) within 3 weeks prior to the first dose of study drug.
  • Currently participating and receiving study therapy or has participated in a study of an investigational agent and received study therapy or used an investigational drug within 4 weeks prior to the first dose of study drug.
  • Received prior anticancer therapy (chemotherapy, targeted therapies, radiotherapy, or immunotherapy) within 21 days, or less than 5 times the half-life of the most recent therapy prior to study Day 1, whichever is shorter. Note: palliative radiation therapy to a small field ≥ 1 week prior to Day 1 of study treatment will be allowed.
  • Patient has not recovered adequately (≤ Grade 1) from AEs and/or complications from any major surgery prior to starting therapy. Patient has received a vaccine within 7 days of planned start of study therapy.
  • Known hypersensitivity to YS-ON-001 components or excipients
  • Known unstable systemic disease including active infection, uncontrolled hypertension, unstable angina, congestive heart failure, myocardial infarction that occurred within a year, severe arrhythmia that required drug treatment, liver disease, kidney disease and metabolic diseases)
  • Known history of splenectomy
  • Known history of chronic alcohol or drug abuse within 6 months
  • PI assessment of subject's lack of willingness to participate and comply with all requirements of the protocol
  • Any other finding which, in the opinion of the PI would significantly increase the risk of having an adverse outcome from participating in this protocol.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03131765


Contacts
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Contact: Shi Zhong Kai +12052229292 PIKA@gmail.com
Contact: Julaiha Batcha 65-62246157 julaiha.batcha.ysbp@gmail.com

Locations
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Singapore
National University Cancer Institute Singapore Recruiting
Singapore, Singapore
Contact: Lee Soo Chin    67795555      
Principal Investigator: Lee Soo Chin         
Sponsors and Collaborators
Yisheng Biopharma (Singapore) Pte. Ltd.
Investigators
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Principal Investigator: Lee Soo Chin National University Cancer Institute, Singapore

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Responsible Party: Yisheng Biopharma (Singapore) Pte. Ltd.
ClinicalTrials.gov Identifier: NCT03131765     History of Changes
Other Study ID Numbers: YS-RVON-001
First Posted: April 27, 2017    Key Record Dates
Last Update Posted: April 27, 2017
Last Verified: April 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Poly I-C
Antiviral Agents
Anti-Infective Agents
Interferon Inducers
Immunologic Factors
Physiological Effects of Drugs